Discover how QbD Group helped Techdow Pharmaceutical, a leading Chinese exporter of complex biologicals, achieve EU GMP certification, Marketing Authorisation, and full commercialisation across Europe.
Techdow Pharmaceutical is a leading Chinese exporter of enoxaparin sodium APIs and low molecular weight heparin (LMWH) injections, complex biological products. To commercialise their biosimilar in Europe, Techdow required end-to-end support spanning development, GMP compliance, regulatory submissions, and post-authorisation services.
Enoxaparin is a demanding biosimilar requiring clinical studies for EU registration, placing it among the more complex biological products to bring to the European market. Techdow faced this challenge as a Chinese manufacturer with no prior foothold in the EU regulatory landscape.
Beyond the regulatory dossier itself, Techdow's Chinese manufacturing facility needed to be aligned with EU GMP standards, a hard prerequisite for any European marketing authorisation. This meant simultaneously managing development activities, clinical evidence generation, manufacturing compliance, and regulatory strategy across multiple years and jurisdictions.
QbD Group provided end-to-end support across every stage of Techdow's EU market entry programme, from early development through to post-authorisation services.
QbD Group coordinated this multi-year programme through SciencePharma, its Poland-based member, ensuring consistent oversight and local regulatory expertise throughout the engagement.
The programme delivered across all critical milestones, taking Techdow from an unfamiliar regulatory landscape to full commercial presence on the European market.
Techdow issued a Letter of Recommendation to SciencePharma, the Polish-based member of QbD Group, reflecting the quality of the partnership and the results delivered throughout this complex, multi-year programme. — Letter of Recommendation — Techdow Pharmaceutical
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